Label: Information for the User

Brevibloc 10 mg/ml Infusion Solution

Esmolol Hydrochloride

Read this label carefully before you start taking this medicine because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

In this label, BREVIBLOC 10 mg/ml infusion solution will be referred to as Brevibloc.

Brevibloc contains a medication called esmolol. It belongs to a group of medications known as “beta blockers”. It works by controlling the frequency and force of your heartbeats. It may also help you reduce your blood pressure.

It is used to treat the following:

• Heart rate problems, if it is too fast
• Cardiac problems and high blood pressure if they occur during or immediately after surgery.

Your doctor will not administer Brevibloc if:

• You are allergic (hypersensitive) to esmolol, any other beta-blocker medication, or any of the other components of this medication (listed in section 6). Symptoms of an allergic reaction include difficulty breathing, wheezing, rash, itching, or swelling of the face and lips.
• You have a very low heart rate (less than 50 beats per minute).
• Your heart rate is high or alternates between low and high.
• You have what is called a "severe heart block"; it is a problem with the electrical impulses that control your heart rate.
• You have low blood pressure.
• You have problems with blood flow to the heart.
• You have severe symptoms of heart failure.
• You are receiving or have recently received verapamil. Brevibloc should not be administered within 48 hours of your last dose of verapamil.
• You have an adrenal gland disease called pheochromocytoma that has not been treated. Pheochromocytoma is produced in the adrenal gland and can cause a sudden increase in blood pressure, severe headaches, sweating, and increased heartbeats.
• You have high blood pressure in the lungs (pulmonary hypertension).
• You have symptoms of asthma that worsen quickly.
• You have elevated acid levels in the body (metabolic acidosis).

Your doctor will not administer Brevibloc if you have any of the above conditions. If you are unsure if you have any of these conditions, talk to your doctor, pharmacist, or nurse before using Brevibloc.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Brevibloc. Your doctor will take special care with this medication if:

• You are receiving treatment for certain heart rhythm disorders called supraventricular arrhythmias and:
• • You have other heart problems or
  • You are taking other heart medications.

The use of Brevibloc in this way may cause adverse reactions that can be fatal, including the following:

• You develop low blood pressure (hypotension). This may be noticed in symptoms such as dizziness or feeling faint, especially when standing up. Low blood pressure usually improves 30 minutes after completing your treatment with Brevibloc.
• You have a low heart rate before treatment.
• Your heart rate decreases to less than 50 or 55 beats per minute. If this happens, your doctor may administer a lower dose or stop treatment with Brevibloc.
• You have heart failure.
• You have a problem with the electrical impulses that control your heart rate (heart block).
• You have an adrenal gland disease called pheochromocytoma that has been treated with medications called "alpha-receptor blockers."
• You are receiving treatment for high blood pressure (hypertension) caused by low body temperature (hypothermia).
• You have bronchospasm or wheezing, such as those characteristic of asthma.
• You have diabetes or low blood sugar. Brevibloc may exacerbate the effects of diabetes medications.
• You develop skin problems, which may be caused by leaks of solution around the injection site. If this happens, your doctor will use a different vein for the injection.
• You have a type of angina (chest pain) called "Prinzmetal's angina."
• You have low blood volume. You may develop low blood pressure (hypotension) more easily
• You have circulatory problems, such as pale fingers (Raynaud's disease) or pain, fatigue, and sometimes a burning, painful sensation in the legs.
• You have kidney problems. If you have kidney failure or need dialysis, you may develop high potassium levels in the blood (hyperkalemia), which can cause severe heart problems
• You have any allergies or are at risk of anaphylactic reactions (severe allergic reactions). Brevibloc may exacerbate allergies and make them more difficult to treat.
• You or a family member has psoriasis (the skin produces scales)
• You have a condition called hyperthyroidism (overactive thyroid gland)

It is usually not necessary to change the dose if you have liver problems.

If any of the above conditions apply to your case (or if you are unsure), consult your doctor, pharmacist, or nurse before administering this medication. You may need to undergo a thorough examination and change your treatment.

Use of Brevibloc with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This includes medications acquired without a prescription, including natural products and herbal remedies. Your doctor will check if any of the medications you are taking may alter the action of Brevibloc.

Especially, inform your doctor, nurse, or pharmacist immediately if you are taking any of the following products:

• Medications that may lower blood pressure or slow the heart rate
• Medications used to treat heart rhythm problems or chest pain (angina) such as verapamil and diltiazem. Brevibloc should not be administered within 48 hours of your last dose of verapamil
• Medications used to treat heart rhythm problems (such as quinidine, disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin, digitalis)
• Nifedipine, which is used to treat chest pain (angina), high blood pressure, and Raynaud's disease
• Medications used to treat diabetes, including insulin and oral medications
• Medications known as ganglion blockers (such as trimetafán)
• Medications used as analgesics, such as non-steroidal anti-inflammatory drugs (NSAIDs)
• Floctafenina, which is an analgesic
• Amisulprida, a medication used to treat mental health problems
• Tricyclic antidepressants (such as imipramine and amitriptyline) or any other medication for mental health problems
• Barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines (such as chlorpromazine, used to treat mental health problems)
• Clozapina, used to treat mental health problems
• Epinephrine, used to treat allergic reactions
• Medications used to treat asthma
• Medications used to treat colds or nasal congestion called "decongestants"
• Reserpine, used to treat high blood pressure
• Clonidina, used to treat high blood pressure and migraine
• Moxonidina, used to treat high blood pressure
• Derivatives of ergot, medications often used to treat Parkinson's disease
• Warfarina, used as an anticoagulant
• Morphine, a very potent analgesic
• Chloride succinylcholine (also known as succinylcholine or esculina) or mivacurio, often used as muscle relaxants during surgery. Your doctor will also need to take special care when using Brevibloc during surgery, when anesthetics and other treatments are administered.

If you are unsure if any of the above conditions apply to your case, talk to your doctor, pharmacist, or nurse before using Brevibloc.

Controls that can be performed while using Brevibloc

The use of medications like Brevibloc over a long period of time may reduce the strength of your heart rate.

Since Brevibloc is only used for a limited time, it is unlikely that this will happen. During treatment, you will be closely monitored, and treatment with Brevibloc will be reduced or stopped if your heart rate strength decreases.

Your doctor will also be able to monitor your blood pressure while you are being treated with Brevibloc.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Brevibloc should not be administered if you are pregnant or think you may be pregnant.

Inform your doctor if you are breastfeeding. Brevibloc may pass into breast milk and, therefore, should not be administered if you are breastfeeding.

Important information about some of the components of Brevibloc

Patients with low-sodium diets should note that this medication contains 700 mg (30.45 mmol) of sodium per bag.

Recommended Dose

Your doctor will decide on the dose of medication you need and the duration of treatment.

Normally, Brevibloc will be administered for more than 24 hours.

How to Administer Brevibloc

Brevibloc is ready for use. It will be administered through a slow injection (infusion) via a needle inserted into a vein in your arm.

Brevibloc should not be mixed with sodium bicarbonate or any other medication.

The treatment is administered in two steps.

• Step one: a high dose is administered for one minute. This will rapidly increase Brevibloc levels in the blood.
• Step two: a lower dose is administered for four minutes.
• Steps one and two can be repeated and adjusted based on how your heart responds. Once an improvement is observed, step one (the high dose) will be interrupted and step two (the lower dose) will be reduced as needed.
• When a stable situation is reached, you may be administered another heart medication while the Brevibloc dose is gradually reduced.
• If your heart rate or blood pressure increases during surgery or postoperatively, higher doses of Brevibloc will be administered for a brief period of time.

Older Adults

Your doctor will start treatment with a lower dose.

Children

Brevibloc should not be administered to individuals under 18 years of age.

Receiving Too Much Brevibloc

If a person with the necessary qualifications and training administers Brevibloc, it is unlikely that you will receive an excessive dose. However, if this occurs, your doctor will stop the Brevibloc treatment and, if necessary, administer additional treatment.

In the event of an overdose or accidental ingestion, contact the Toxicology Information Service, Phone 915 620 420, indicating the medication and the amount administered.

Not Receiving a Dose of Brevibloc

If a person with the necessary qualifications and training administers Brevibloc, it is unlikely that you will not receive any dose. However, if you believe you have not received any, speak with your doctor, pharmacist, or nurse as soon as possible.

Stopping Brevibloc Use

Stopping Brevibloc treatment abruptly may cause symptoms such as rapid heart rate (tachycardia) and high blood pressure (hypertension) to return. To avoid this, your doctor should gradually discontinue treatment. However, if you have coronary artery disease (which may be associated with angina or myocardial infarction), your doctor should exercise special caution when discontinuing Brevibloc treatment.

If you have any doubts about the use of this product, ask your doctor, nurse, or pharmacist

Like all medications, this medication may cause side effects, although not everyone will experience them. Most side effects disappear 30 minutes after stopping treatment with Brevibloc. The following side effects have been reported with Brevibloc:

If you notice any of the following side effects, which may be serious, inform your doctor, nurse, or pharmacist. The infusion will also need to be interrupted.

Very common(may affect more than 1 in 10 people)

• Low blood pressure, which can be quickly corrected by reducing the dose of Brevibloc or stopping treatment. Your blood pressure will be monitored frequently during treatment.
• Excessive sweating.

Common(may affect less than 1 in 10 people)

• Loss of appetite
• Sensation of anxiety or depression
• Dizziness
• Drowsiness
• Headache
• Prickling or pins and needles
• Difficulty concentrating
• Sensation of confusion or agitation
• General discomfort (nausea and vomiting)
• Sensation of weakness
• Sensation of fatigue (fatigue)
• Irritation and hardening of the skin at the site where Brevibloc has been injected

Uncommon(may affect less than 1 in 100 people)

• Mental disturbances
• Sudden loss of consciousness
• Sensation of fainting or fainting
• Seizures (crises or convulsions)
• Speech disturbances
• Vision disturbances
• Low heart rate
• Problems with the electrical impulses that control your heart rate
• High blood pressure in the pulmonary arteries
• Heart failure, inability of the heart to pump enough blood
• Alteration of heart rhythm, known as palpitations (ventricular extrasystoles)
• Heart rate disorder (nodal rhythm)
• Chest discomfort caused by reduced blood flow through the coronary arteries (angina pectoris)
• Poor circulation in arms or legs
• Pale or flushed appearance
• Liquid in the lungs
• Difficult breathing or chest pressure that makes breathing difficult
• Whistling
• Blocked nose
• Auscultation sounds
• Changes in taste
• Indigestion
• Constipation
• Dry mouth
• Pain in the stomach area
• Decoloration of the skin
• Redness of the skin
• Pain in muscles or tendons, including those around the shoulders and ribs
• Discomfort while urinating (urinary retention)
• Sensation of cold or elevated temperature (fever)
• Pain and swelling (edema) of the vein where Brevibloc has been injected
• Sensation of itching or hives at the injection site

Very rare(may affect less than 1 in 10,000 people)

• Severe reduction in heart rate (sinus arrest)
• Absence of electrical activity in the heart (asystole)
• Sensitive blood vessels with a red and warm area of skin (thrombophlebitis)
• Dead skin caused by leaks of solution around the injection site.

Unknown frequency(unknown number of people affected)

• Elevated potassium levels in the blood (hyperkalemia)
• Elevated acid levels in the body (metabolic acidosis)
• Accelerated heart rate (accelerated idioventricular rhythm)
• Spasm of the coronary artery
• Failure of normal blood circulation (cardiac arrest)
• Poriasis (skin produces scales)
• Swelling of the skin of the face, limbs, or tongue or swelling of the throat (angioedema)
• Hives (urticaria)
• Inflammation of a vein or vesiculation at the infusion site.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children
• Do not use Brevibloc after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not remove the overwrap until the time of use
• Do not store at a temperature above 25º C.
• Do not refrigerate or freeze
• The opened product is stable for 24 hours at 2º-8º C. However, it should be used immediately once opened
• Do not use Brevibloc if you observe particles or discoloration in the solution

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE Drop-Off Point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Brevibloc

• The active ingredient is esmolol hydrochloride. One ml contains 10 mg of esmolol hydrochloride. A 250 ml bag contains 2500 mg of esmolol hydrochloride.
• The other components are: sodium acetate, glacial acetic acid, sodium chloride, and sterile water (designated as "sterile water for injection preparations"). Hydroxide sodium or hydrochloric acid may be added to ensure correct pH adjustment.

Appearance of Brevibloc and contents of the package

Brevibloc is a sterile, transparent, colorless, or slightly yellowish solution for intravenous infusion (slow injection). It is available in 250 ml plastic bags.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Baxter S.L.

Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

Responsible for manufacturing

Brevibloc in Viaflo bag is manufactured by

Vantive Manufacturing Limited

Moneen Road

Castlebar, Co. Mayo

F23 XR63, Ireland

Brevibloc in Intravia bag is manufactured by

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

CountryName

BelgiumBrevibloc 10 mg/ml, solution for infusion

CyprusBrevibloc 10 mg/ml Δι?λυμα για ενδοφλ?βια ?γχυση

DenmarkBreviblocinfusionsvæske, opløsning

FinlandBrevibloc 10 mg/ml infuusioneste, liuos

GermanyBrevibloc 10 mg/ml Infusionslösung

IrelandBrevibloc Premixed 10 mg/ml, Solution for Infusion

NetherlandsBrevibloc 10 mg/ml, oplossing voor infusie

NorwayBrevibloc 10 mg/ml, Infusjonsvæske, oppløsning

PortugalBrevibloc Premixed 10 mg/ml, Solução para perfusão

SpainBrevibloc 10 mg/ml solución para perfusión

SwedenBrevibloc 10 mg/ml, Infusionsvätska, lösning

United KingdomBrevibloc Premixed 10mg/ml, Solution for Infusion

(Northern Ireland)

Last review date of this leaflet November 2022.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Baxter, Brevibloc, Intravia, and Viaflo are registered trademarks of Baxter International Inc